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Trial record 50 of 3404 for:    Recruiting, Not yet recruiting, Available Studies | Pain

Evidence-based Pain Intervention for Veterans: AtEase for Chronic Pain

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ClinicalTrials.gov Identifier: NCT03963908
Recruitment Status : Not yet recruiting
First Posted : May 27, 2019
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Sara Johnson, Pro-Change Behavior Systems

Brief Summary:
This study is a randomized controlled trial to test the efficacy AtEase, a pain self-management app in a sample of Veterans with chronic musculoskeletal pain. The primary outcome is changes in PEG scores from baseline to final follow-up (12 months).

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: AtEase Behavioral: Chronic Pain Education Not Applicable

Detailed Description:

The primary objectives of this project are to develop and examine the effectiveness of a mobile app (AtEase) that is designed to provide tailored behavior change guidance to promote pain self-management, healthy sleep habits, and effective stress management in a randomized clinical trial including 262 Veterans with chronic pain.

Veterans will be recruited from VA Connecticut Healthcare, as well as from numerous diverse community recruitment channels (including employers, community groups that provide services for Veterans, Student Veterans of America, and social media).

Eligible Veterans will be randomized to receive access to AtEase or the comparison intervention (a mobile-optimized adaptation of Chronic Pain Education for Veterans) for a total of 6 months. AtEase is a tailored pain self-management mobile app that tailors participant's feedback based on readiness to engage in pain self-management and preference for self-management strategies. Chronic Pain Education for Veterans is a free VA-endorsed publicly available pain management online educational curriculum that provides cognitive-behavioral therapy-based pain self-management materials.

Between the baseline assessment and the 6-month follow up assessment, participants will have unlimited access AtEase or the Chronic Pain Education for Veterans program. All participants will complete follow-up assessments at 6 months and 12-months post-baseline.

The primary outcome will be a comparison of PEG scores at 12 months follow-up. Secondary outcomes will include pain,Global Impression of Change; readiness to self-manage pain, manage stress, and engage in healthy sleep habits; well-being; and Post Traumatic Stress Disorder Checklist scores.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study involves a 2-group X 3 occasion randomized trial that will examine whether AtEase produces more significant improvements in PEG scores (which reflect total pain intensity and pain interference) than a comparison intervention (i.e., an existing online pain self-management intervention entitled Chronic Pain Education for Veterans).
Masking: Single (Participant)
Masking Description: Participants will be blinded to group assignment.
Primary Purpose: Supportive Care
Official Title: Evidence-based Pain Intervention for Veterans: Leveraging Mobile & Social Media: A Randomized 262-subject Controlled Trial of AtEase, a Pain Self-management App in the Treatment of Chronic Pain in Veterans
Estimated Study Start Date : June 10, 2019
Estimated Primary Completion Date : November 10, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Intervention
AtEase is a mobile app designed to promote pain self-management, healthy sleep habits, and effective stress management. It includes a tailored Newsfeed that updates regularly with articles, activities, videos, and quizzes chosen for the user; a chat feature that asks questions and provide tailored feedback; a Message Center; and a Pain Tracker. Users can interact with AtEase as often as they like for six months.
Behavioral: AtEase
AtEase is a tailored pain self-management mobile app that tailors participant's feedback based on readiness to engage in pain self-management and preference for self-management strategies.

Active Comparator: Comparison
Chronic Pain Education for Veterans is a VA-endorsed pain management online educational curriculum that provides CBT pain self-management materials. Users randomized to the comparison condition will have unlimited access for 6 months.
Behavioral: Chronic Pain Education
CBT-based Education on Pain Self-Management for Veterans




Primary Outcome Measures :
  1. PEG [ Time Frame: Baseline to 12 months ]
    The PEG is a multi-dimensional three-item assessment that measures average pain rating, as well as both emotional and physical functioning.


Secondary Outcome Measures :
  1. Global Impression of Change [ Time Frame: 12 months ]
    The Global Impression of Change scale is recommended43 as a core outcome measure in pain studies. It is a single item that asks participants to describe any change in their condition as a result of using the program. Response options range from 1 = No change (or condition has gotten worse) to 7 = A great deal better, and a considerable improvement that has made all the difference.

  2. Pain Level [ Time Frame: Baseline to 12 months ]
    Level of pain will also be assessed by asking participants to rate their pain 1) right now, 2) usual level of pain in the last week, 3) best level of pain in the last week, and 4) worst level of pain in the last week. All ratings are on a scale of 0-10, with zero equal to no pain, and 10 equal to worst pain.

  3. Readiness to self-manage pain [ Time Frame: Baseline to 12 months ]
    Changes in participant's stage of change for using self-management strategies using a stage of change algorithm

  4. Stage of change for healthy sleep habits [ Time Frame: Baseline to 12 months ]
    Readiness to get at least 7 hours of sleep a night

  5. Stage of change for stress management [ Time Frame: Baseline to 12 months ]
    Readiness to effectively manage stress

  6. Post-Traumatic Stress Disorder (PTSD) Checklist (PCL-5) [ Time Frame: Baseline to 12 months ]
    PTSD symptoms will be measured using the 20-item PCL-5, which assesses the 20 symptoms of PTSD.

  7. Well-Being [ Time Frame: Baseline to 12 months ]
    Well-being will be assessed using the Cantril Self-Anchoring Scale, which asks participants to imagine a ladder with steps numbered from 0 to 10, with the top representing the best possible life and the bottom representing the worst possible life. Participants indicate where they feel their life falls currently and where it will fall in five years.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female Veteran
  • Chronic musculoskeletal pain defined as (numeric rating scale of >4) (10 point scale) for > 3 months.43
  • Internet connectivity via tablet or mobile phone.

Exclusion Criteria:

  • Life-threatening condition or acute medical conditions that precludes participation
  • Psychiatric conditions that could impair participation
  • Suicidal ideation or intent
  • Inability to read or speak English
  • Unwilling or unable to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03963908


Contacts
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Contact: Marissa Joly, BA 4013602985 mjoly@prochange.com

Sponsors and Collaborators
Pro-Change Behavior Systems
Investigators
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Principal Investigator: Sara Johnson, PhD Pro-Change Behavior Systems, Inc.

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Responsible Party: Sara Johnson, Co-President & CEO, Pro-Change Behavior Systems
ClinicalTrials.gov Identifier: NCT03963908     History of Changes
Other Study ID Numbers: 9R44AT009675-02 ( U.S. NIH Grant/Contract )
First Posted: May 27, 2019    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sara Johnson, Pro-Change Behavior Systems:
chronic pain
stage of change
pain self management
mobile applications
Transtheoretical Model

Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms